immunological response to an extra mumps immunization (in healthy volunteers)
Conditions
Interventions
Trade Name: M-M-RVAXPRO
Pharmaceutical Form: Powder and solvent for suspension for injection
Sponsors
RIVM
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy young adult 18-25 years of age. Previously been immunized with two doses of the MMR vaccine according to the Dutch NIP (MMR-1 at ~14 months and MMR-2 at ~9 years). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Medical conditions that will severely affect immunological responses to vaccinations, such as, but not limited to, cancer or an immune disorder. Vaccination should be postponed during any illness with fever >38.5°C until the fever has disappeared. Vaccination with any vaccine during the first two weeks before and four weeks after MMR-3. An additional MMR vaccination during the study. Coagulation disorder and/or anticoagulant medication. Be or have been under immunosuppressive medical treatment, like cytostatics, high-dose corticosteroids, immune globulins, blood or plasma transfusions that might interfere with the results of the study (within the previous 3 months). Have or previously had clinical symptoms of mumps virus infection. Have or previously had cases of mumps disease within your Household. Had experienced a previous severe adverse reaction to any vaccine. Being pregnant; Furthermore, pregnancy should be avoided for 1 month following vaccination. Breast-feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of third dose of MMR in young adults 18-25 years of age on the development of mumps-specific serum VN antibody titers (against vaccine- and currently circulating wild-type mumps virus strains (genotype G)) and mumps-specific serum antibody IgG titers (including antibody avidity), 10 days, 4 weeks , 1 year and 3 years following vaccination;Secondary Objective: To assess the local and systemic tolerance of a third dose of MMR. To assess the short- and long-term (4 weeks and 1 year) mumps-specific IgA and IgG (in saliva) following a third dose of MMR. To explore the short- and long-term (4 weeks and 1 year) mumps-specific cell-mediated responses, i.e. presence and frequency of mumps-specific memory and effector T- and B-cells following a third dose of MMR. To assess the short- and long-term (10 days, 4 weeks, 1 year and 3 years) IgG response against measles and rubella (components of the MMR vaccine) following a third dose of MMR. ;Primary end point(s): 1. Mumps-specific VN antibody titers (against the vaccine and currently circulating mumps virus strains) and IgG antibody titers (including antibody avidity) measured in serum samples following a third vaccine dose of MMR in healthy young adults (18-25 years).;Timepoint(s) of evaluation of this end point: 1. prior to and 10 days, 4 weeks , 1 year and 3 years following a third vaccine dose of MMR. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Frequency and intensity of the local and systemic tolerance. 3. Mumps-specific IgA and IgG (saliva*) following a third vaccine dose of MMR. 4. The presence and frequency of mumps-specific memory and effector T- and B-cells in peripheral blood following MMR-3, in a voluntary subset of the participants. 5. Serum IgG response against measles and rubella (components of the MMR vaccine) following a third vaccine dose of MMR.;Timepoint(s) of evaluation of this end point: 2. 0-14 days post vaccination. 3. Prior to and 10 days, 4 weeks and 1 year following a third vaccine dose of MMR. 4. Prior to, 4 weeks and 1 year following a third vaccine dose of MMR. 5. Prior to and 10 days, 4 weeks, 1 year en 3 years following a third vaccine dose of MMR. *Saliva not collected at 10 days following immunisation | — |
Countries
Netherlands
Contacts
Public ContactClinical Expertise Centre
RIVM
Outcome results
None listed